12-week exercise program for people with hereditary transthyretin (ATTRv) amyloidosis
Effects of a 12-week Exercise Intervention on Physical and Mental Health in Hereditary ATTR (ATTRv) Amyloidosis
This 12-week exercise program will try to see if regular physical activity improves fitness and mental well-being for people with hereditary ATTR (ATTRv) amyloidosis in early stages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maia Academic / other |
| Locations | 1 site (Maia, Porto District) |
| Trial ID | NCT07033715 on ClinicalTrials.gov |
What this trial studies
This interventional study delivers a supervised 12-week exercise program to people with hereditary transthyretin-related amyloidosis (ATTRv) who are in disease stage 1 or 2. Participants will be recruited in Portugal and will undergo baseline and post-intervention measures of physical fitness, mental health, and health-related quality of life while continuing their current medical therapies. The protocol explicitly includes patients receiving newer ATTR therapies and expands outcomes beyond physical performance to capture psychological and HRQoL effects. By comparing outcomes before and after the intervention, researchers aim to add evidence on the safety and potential benefits of exercise in this under-studied population.
Who should consider this trial
Good fit: Adults with genetically confirmed hereditary ATTR (ATTRv) amyloidosis in disease stage 1 or 2 who live in Portugal, have no medical contraindication to exercise, and can give informed consent are ideal candidates.
Not a fit: People with advanced disease beyond stage 2, those with a medical contraindication to exercise, or those who had a liver transplant within the past six months are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve physical fitness, reduce mental burden, and enhance overall health-related quality of life for people with early-stage ATTRv.
How similar studies have performed: Only a few prior studies—mainly in liver-transplanted patients—have reported physical fitness benefits, while mental health effects in non-transplanted ATTRv patients remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ATTRv Amyloidosis patients living in Portugal; * Disease stage 1 or 2; * No medical contraindication for exercising; * Ability to provide informed consent. Exclusion Criteria: \- Having undergone a liver transplant in the past 6 months.
Where this trial is running
Maia, Porto District
- University of Maia — Maia, Porto District, Portugal (Recruiting)
Study contacts
- Study coordinator: Cláudia F. Barata, PhD
- Email: claudiapfb19@gmail.com
- Phone: +351915381161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.